Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves

Device: EBV implantation

In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.

Other Name: (Zephyr EBV)

Active Comparator: Intrabronchial valves (IBV)

Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves

Device: IBV implantation

In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.

Other Name: (Spiration IBV)

Detailed Description:

Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Eligibility

Ages Eligible for Study:

30 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %

heterogeneous emphysema

Exclusion Criteria:

homogeneous emphysema

significant bronchiectasis

severe concomitant diseases

pregnancy

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01457833